p3 study to evaluate efficacy and safety of amg 531 in thrombocytopenic japanese subjects with immune (idiopathic) thrombocytopenic purpura

Conditions: Idiopathic Thrombocytopenic Purpura

Summary: the purpose of this study is to evaluate the efficacy and safety of amg 531 compared with placebo in thrombocytopenic japanese subjects with immune (idiopathic) thrombocytopenic purpura (itp) .


Eligibility criteria:
inclusion criteria: * japanese patients with diagnosis of itp according to the diagnostic criteria proposed by research committee for idiopathic hematopoietic disorders of the ministry of health, labour and welfare \[mhlw\] (revised in 1990) at least 6 months before the first screening visit * the mean of the 3 scheduled platelet counts taken at the scheduled visits during the screening period must be ≤ 30 x 10\^9/l, with no individual count \> 35 x 10\^9/l * eastern cooperative oncology group (ecog) performance status of 0 to 2 * subjects must be ≥ 20 years of age at the time of obtaining the informed consent * have received at least 1 prior treatment for itp * if known helicobacter pylori positive, having completed one course of helicobacter pylori eradication therapy at least 12 weeks before the first screening visit * a hemoglobin value taken at scheduled visit during the screening period must be ≥ 10 g/dl * a serum creatinine concentration taken at scheduled visit during the screening period must be ≤ 2 mg/dl * adequate liver function, as evidenced by a total bilirubin taken at scheduled visit during the screening period ≤ 1.5 times of the upper limit of the normal range (except for patients with a confirmed diagnosis of gilbert's disease) or an alanine aminotransferase and aspartate aminotransferase taken at the screening visit ≤ 3 times of the upper limit of the normal range exclusion criteria: * any known history of bone marrow stem cell disorder. any abnormal bone marrow findings other than those typical of itp. * any active malignancy. if prior history of cancer other than basal cell carcinoma or cervical carcinoma in situ, no treatment or active disease within 5 years before the first screening visit. * documented diagnosis of arterial thrombosis (eg, stroke, transient ischemic attack, or myocardial infarction); history of venous thrombosis (eg, deep vein thrombosis, pulmonary embolism) and receiving anticoagulation therapy at the first screening visit. * documented diagnosis of anti phospholipid antibody syndrome * currently receiving any treatment for itp except oral corticosteroids, azathioprine and/or danazol administered at a constant dose and schedule from at least 4 weeks prior to the first screening visit * received intravenous immunoglobulin, anti d immunoglobulin, or any drug administered to increase platelet counts (eg, immunosuppressants except azathioprine) within 2 weeks before the first screening visit * have had a splenectomy for any reason within 12 weeks before the first screening visit * past or present participation in any study evaluating pegacaristim (polyethylene glycol-conjugated recombinant human megakaryocyte growth and development factor, krn9000), eltrombopag (sb 497115), recombinant human thrombopoietin, amg 531, or other mpl stimulation product * received hematopoietic growth factors (eg, granulocyte colony stimulating factor, macrophage colony stimulating factor, erythropoietin, interleukin 11) for any reason within 4 weeks before the first screening visit * received any anti malignancy agents (eg, cyclophosphamide, 6 mercaptopurine, vincristine, vinblastine, interferon alfa) for any reason within 8 weeks before the first screening visit * received any monoclonal antibody drugs (eg, rituximab) for any reason within 14 weeks before the first screening visit * less than 4 weeks since receipt of any therapeutic drug or device that is not mhlw approved for any indication before the first screening visit * pregnant or breast feeding * subjects of reproductive potential who are not using adequate contraceptive precautions, in the judgment of the investigator * known severe drug hypersensitivity * concerns for subject's compliance with the protocol

Keywords: amg 531 idiopathic thrombocytopenic purpura itp thrombocytopenia japan placebo controlled phase 3